Cirrus Hd-oct recall
CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
Why was Cirrus Hd-oct recalled?
Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All instrument serial numbers running running software versions 11.5, 11.5.1 and 11.5.2. with ONH Angiography 4.5x4.5mm Scan
- Product
- CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
- Recalling firm
- Carl Zeiss Meditec, Inc.
- Quantity
- 1,272 devices
- Distribution
- U.S Nationwide Distribution.: OH, CA, IN, AR, IA, LA, WI, OK, IL, OR, AL, KY, WY, WA, MN, NE, PA, SD, AZ, PR, TN, GA, FL, DE, NY, NH, TX, MS, MA, NV, UT, WV, ME, CO, AK, NM, KS, MO, MI, MD, ID, CT, NJ, MT, NC, VA, HI, VT, ND, SC, DC, RI
- Recall date
- March 16, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)